Beirut, Lebanon, July 13, 2015– Novartis announced that the US Food and Drug Administration (FDA) has approved its medicine LCZ696, for the treatment of heart failure with reduced ejection fraction. The new drug will be available on prescription for patients whose condition is classified by New York Heart Association (NYHA) as class II-IV, indicated to reduce the risk of cardiovascular death and heart failure hospitalization. It is usually administered in conjunction
with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker.1
“Despite the uncertainty and high financial risk we designed the world’s largest heart failure trial to compare LCZ696 to the previous gold standard. As a result millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital,” said David Epstein, Division Head at Novartis Pharmaceuticals.
The FDA’s decision is based on results from the 8,442-patient PARADIGM-HF study which was stopped early when it was shown that LCZ696 significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril.1 At the end of the study, patients with reduced ejection fraction who were given the new drug were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril.Analysis of safety data showed that the new medicine had a similar tolerability profile to enalapril.
“The very meaningful survival advantage of LCZ696 seen in the PARADIGM-HF trial should persuade physicians to consider the new drug for all appropriate patients, in place of traditional ACE inhibitors or angiotensin receptor blockers,” said Dr. Milton Packer, Professor and Chair for the Department of Clinical Sciences at University of Texas Southwestern Medical Center, Texas, USA. “LCZ696 is expected to change the management of patients with HFrEF for years to come.”
Nearly 26 million people worldwide suffer from heart failure and about half have the reduced ejection fraction form2. Heart failure is a
debilitating, life-threatening condition in which the heart cannot pump enough blood around the body. Patients face a high risk of death, repeated hospitalizations and symptoms such as breathlessness, fatigue and fluid retention significantly impact quality of life.4
LCZ696 is currently undergoing review by Health Authorities around the world, including in Canada, Switzerland and the EU.
About LCZ696
LCZ696 is a first in class medicine (an ARNI, Angiotensin Receptor Neprilysin Inhibitor) that reduces the strain on the failing heart. A twice-a-day tablet, it acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS).5
Results from the 8,442 patient PARADIGM-HF study showed,versus enalapril, LCZ6961:
– reduced the risk of death from cardiovascular causes by 20%
– reduced heart failure hospitalizations by 21%
– reduced the risk of all-cause mortality by 16%
Overall there was a 20% risk reduction on the primary endpoint, a composite measure of CV death or time to first heart failure hospitalization.
Fewer patients on LCZ696 discontinued study medication for any adverse event compared to those on enalapril.The LCZ696 group had more hypotension and non-serious angioedema but less renal impairment, hyperkalemia and cough than the enalapril group.1